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Recall Observatory FDA recall evidence

Drug product

SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen, 53mL/1.8fl.oz., OTC, Distributed by: EVANS, Made in China

D-1532-2019

April 01, 2019

Class III

Product summary

Firm
NingBo Huize Commodity Co.,Ltd.
Event
Event 83018
Status
Terminated
Classification
Class III
Quantity
10, 000
Official record key
drug-enforcement:D-1532-2019

Official wording

Reason: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

Code information: Lot #: 20180709, Exp 07/08/2020; 20180710, Exp 07/09/2020

Distribution pattern: Foreign manufacturer located in China and distributed to seven consignees located in China.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP deviations